BSI Medical Devices’ Post

The 26 May deadline for manufacturers to have an MDR compliant QMS and to lodge an application with a Notified Body, is almost here! Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” last episode. Stay tuned for the upcoming video series and visit our MDR dedicated webpage: https://lnkd.in/eVRKdnWD #BSI #MedicalDevices #StepsTowardsMDRTransition

The 26 May deadline for manufacturers to have an MDR compliant QMS and to lodge an application with a Notified Body, is almost here! Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” last episode. Stay tuned for the upcoming video series and visit our MDR dedicated webpage: https://lnkd.in/eSDpbDFM #BSI #MedicalDevices #StepsTowardsMDRTransition

The 26 May deadline for manufacturers to have an MDR compliant QMS and to lodge an application with a Notified Body, is almost here! Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” last episode. Stay tuned for the upcoming video series and visit our MDR dedicated webpage: https://gag.gl/ebjTjy #BSI #MedicalDevices #StepsTowardsMDRTransition

The 26 May deadline for manufacturers to have an MDR compliant QMS and to lodge an application with a Notified Body, is almost here! Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” last episode. Stay tuned for the upcoming video series and visit our MDR dedicated webpage: https://lnkd.in/eNC_JHti #BSI #MedicalDevices #StepsTowardsMDRTransition

📅 Is your medical device company ready for 26 May 2024? A reminder of your obligations: 26 May 2024 - Manufacturers must have a quality management system (QMS) compliant to Article 10(9) of the MDR and initiate a formal application with a Notified Body for MDR Conformity Assessment. 26 September 2024 A formal agreement with a Notified Body must be signed, ensuring appropriate surveillance for legacy devices. #mdr

Follow up to previous post regarding Regulation 2023/607. TEAM-NB unveils crucial insights on New MDR Transition Timelines and Notified Body Capacity. Notified bodies are sounding the alarm as MDR applications dipped post-2022. With extended timelines in play, collaboration between manufacturers and notified bodies is key to a seamless transition. Amending regulation brings a phased approach, but fixed deadlines (May 2024 for applications, 2027/2028 for MDR certification) remain. Don't wait till the eleventh hour – early submissions prevent capacity crunch for notified bodies. Despite challenges, notified bodies gear up to certify all devices under MDR before the new deadlines. Feel free to reach out to MedQR Consulting for any additional Regulatory Affairs support you may require. #MedicalDeviceRegulations #MedQRconsulting

🌟 Last call for MDR transitional period deadline! 🌟 We would like to once more remind medical device manufacturers, that the deadline for using the MDR transitional period on the 26th of May is rapidly approaching! If your company has not yet taken actions, the time is running out soon. In order to benefit from the extended transitional period, manufacturers or their authorized representatives must submit a formal MDR conformity assessment application by May 26, 2024, and secure a written agreement with a Notified Body by September 26, 2024! The extension applies under certain conditions that also include the establishment of an MDR-compliant Quality Management System by May 26, 2024. Feel free to contact sales@mdsfinland.com / +358 50 552 8828 for more information about our services related to the MDR transition! You can also book a meeting with us at: https://lnkd.in/d8vujjZW #MDR #IVDR #MedicalDevices #ISO13485 #RegulatoryAffairs #QualityManagement #QMS

The recent EU MDR transition delay has provided some alleviation and more time to prepare. However, it has not changed the requirements to demonstrate compliance under EU MDR. This webinar gives an update on the latest news from the EU, including a review of regulation 2023/607, the relevant MDCG guidance documents, and comments from the European Association for Medical Devices of Notified bodies. The presenter also goes through techniques and tips to prepare your technical documentation per Annex II and Annex III, as well as ways to respond to your Notified Body. Watch the webinar for free here >> https://bit.ly/3PhBlFV #eumdr #medicaldevices #technicaldocumentation #medtech #greenlightguru

Read this important post from BSI Medical Devices and see what we can bring to your business.

On May 26, 2024, medical device companies must submit a conformity assessment application and implement a quality management system (QMS) according to the latest EU MDR guidelines to sell their medical devices in Europe. Read our blog to learn key requirements and common hurdles of EU MDR compliance and discover how Arena’s cloud-native QMS solution helps ensure compliance. https://bit.ly/4dIJdLR #EUMDR #medicaldevices #qms